Cardiac Pacing,ArtificialNCT00417092
Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)
A study testing Postoperative Pacing in people with Cardiac Pacing,Artificial and Coronary Artery Bypass, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing,Artificial, Coronary Artery Bypass, Ventricular Function, Left
- What is being tested?
- Postoperative Pacing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective or urgent coronary artery bypass grafting
- Preoperative ejection fraction less than 40%
Who cannot join
- Existing permanent pacemaker or ICD
- Concomitant valve surgery
- Preoperative cardiovascular instability requiring intubation or IABP use
- Chronic renal failure requiring dialysis
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery
Lübeck, Schleswig-Holstein, 23538
About this study
The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.
Read the detailed description
Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.
- Being tested
- Postoperative Pacing
- Keywords
- coronary artery bypass grafting, reduced left ventricular function, postoperative pacing, cardiac resynchronization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative PacingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intensive Care Treatment
Secondary outcomes (9)
30 day mortality
Major adverse events
Duration of Hospital Stay
Hemodynamic parameters
Inotrope use
Atrial fibrillation
Ventricular tachycardia / ventricular fibrillation
Renal function
Stability of pacing wires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startDec 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacing,ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Uwe KH Wiegand, MD, Study director, University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417092
- Sponsor's protocol ID
- UL 04-156
- Status last verified
- Sep 2007
- First submitted
- 28 Dec 2006
- Last updated
- 24 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)
- ClinicalTrials.gov ID
- NCT00417092
- Acronym / sponsor ID
- UL 04-156
- Keywords
- coronary artery bypass grafting, reduced left ventricular function, postoperative pacing, cardiac resynchronization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.
Detailed description
Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective or urgent coronary artery bypass grafting
- Preoperative ejection fraction less than 40%
Key exclusion criteria (5 listed)
- Existing permanent pacemaker or ICD
- Concomitant valve surgery
- Preoperative cardiovascular instability requiring intubation or IABP use
- Chronic renal failure requiring dialysis
- Failure to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Pacing | Procedure or surgery | – |
Primary outcome
Duration of Intensive Care Treatment
9 secondary outcomes
30 day mortality
Major adverse events
Duration of Hospital Stay
Hemodynamic parameters
Inotrope use
Atrial fibrillation
Ventricular tachycardia / ventricular fibrillation
Renal function
Stability of pacing wires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe KH Wiegand, MD study director
University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Pacing in people with Cardiac Pacing,Artificial and Coronary Artery Bypass, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Intensive Care Treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007; AzTrials last refreshed its copy on 7 Nov 2026.